Persons infected with HBV are at increased risk of developing significant liver disease, including cirrhosis, or permanent scarring of the liver, as well as liver failure and cancer. According to the Hepatitis B Foundation, HBV is the cause of up to 80% of liver cancers, and liver cancer patients typically have a five-year survival rate of only 15%. The WHO estimates that more than 780,000 people die every year due to the consequences of hepatitis B disease.
HBV is often asymptomatic until significant liver damage has occurred. Estimates in a peer-reviewed publication indicate that in the United States only 20% to 30% of infected patients are aware of their disease, and that only approximately half of those aware are actually under physician care. Approximately 50,000 patients, or less than 5% of the chronically infected patients in the United States, are being treated with prescriptions for HBV at a given time, meaning that the vast majority of HBV patients in the United States are not receiving any treatment for the disease.
According to the American Association for the Study of Liver Diseases currently approved treatments for HBV are limited to nucleoside or nucleotide analogs, which inhibit the viral polymerase, and injections of interferon alpha, a naturally occurring protein in the body that stimulates the immune system’s response to infection. Since currently available therapies generally only suppress the virus without delivering a cure, patients require chronic treatment, and may experience significant side effects associated with the long term use of these drugs.
A significant unmet medical need remains for HBV patients and their healthcare providers. Even though all chronic HBV patients could benefit from treatment, current clinical guidelines only recommend therapy for patients in which HBV is causing progression of liver disease, which is approximately one-third to one-half of chronically infected HBV patients. We believe that HBV treatment can be transformed by providing a curative regimen with a finite treatment duration that could reduce viral resistance, increase adherence and eliminate the need for costly life-long treatment and physician monitoring.